BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUNGER HOLDER/TRACK II

    MDR report key: 533798 · Received March 12, 2004

    Report

    Report Number
    1036813-2004-00007
    Event Type
    Malfunction
    Date Received
    March 12, 2004
    Date of Event
    February 12, 2004
    Report Date
    February 12, 2004
    Manufacturer
    MEDEX
    Product Code
    FIH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PLUNGER HOLDER/TRACK II WAS RECEIVED FOR PERIODIC MAINTENANCE. DURING MEDEX' IN-HOUSE TESTING, THE HEX VALUE WAS NOT GREATER THAN CO ON THREE OF THE PLUNGER HOLDERS, WHICH WOULD HAVE CAUSED THE SYRINGE PUMP TO FAIL TO ALERT "LOAD SYRINGE PLUNGER" OR "OCCLUSION" DEPENDING ON THE PUMP'S SOFTWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUNGER HOLDER/TRACK II PLUNGER HOLDER/TRACK II FIH MEDEX PLUNGER HOLDER/TRACK II NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA